Confidential Disclosure Agreement In Clinical Research Template for Denmark

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Confidential Disclosure Agreement In Clinical Research

Document background
The Confidential Disclosure Agreement In Clinical Research is essential for organizations conducting or participating in clinical research activities in Denmark. It is specifically designed to protect confidential information exchanged during clinical research projects, including sensitive patient data, research protocols, study results, and proprietary methodologies. This agreement type is crucial when research organizations, pharmaceutical companies, or healthcare institutions need to share sensitive information while ensuring compliance with Danish law, including the Danish Data Protection Act and Medicines Act, as well as EU regulations such as GDPR and the Clinical Trials Regulation. The document is particularly relevant for multi-party research collaborations where protection of intellectual property, patient data, and research methodologies is paramount. It includes specific provisions addressing the unique aspects of clinical research data protection within the Danish legal framework.
Suggested Sections

1. Parties: Identification of the disclosing and receiving parties, including full legal names, registration numbers, and addresses

2. Background: Context of the clinical research project and purpose of information sharing

3. Definitions: Define key terms including 'Confidential Information', 'Clinical Research Project', 'Study Data', and 'Trade Secrets'

4. Scope of Confidential Information: Detailed description of what constitutes confidential information in the clinical research context

5. Permitted Use: Specific purposes for which the confidential information may be used, limited to the clinical research project

6. Confidentiality Obligations: Core obligations regarding protection, non-disclosure, and handling of confidential information

7. Data Protection and GDPR Compliance: Specific provisions relating to handling of personal data and compliance with GDPR and Danish data protection laws

8. Security Measures: Required technical and organizational measures for protecting confidential information

9. Return or Destruction: Obligations regarding return or destruction of confidential information upon termination

10. Term and Termination: Duration of the agreement and termination provisions

11. Survival: Provisions that continue after termination, particularly confidentiality obligations

12. Governing Law and Jurisdiction: Specification of Danish law and jurisdiction

Optional Sections

1. Third Party Disclosure: Required when confidential information may need to be shared with approved third parties such as contract research organizations or regulatory authorities

2. Publication Rights: Include when parties need to address rights to publish research results while protecting confidential information

3. Intellectual Property Rights: Include when confidential information may involve patentable inventions or other IP rights

4. Clinical Trial Regulations Compliance: Include when the CDA specifically relates to a clinical trial subject to EU Clinical Trials Regulation

5. Breach Notification: Detailed procedures for handling and reporting confidentiality breaches, particularly relevant for high-sensitivity data

6. Insurance and Liability: Include when parties want to specify liability limitations and insurance requirements

7. Language: Include when agreement needs to be in both English and Danish with specification of prevailing version

Suggested Schedules

1. Schedule 1 - Description of Clinical Research Project: Detailed description of the research project and context for information sharing

2. Schedule 2 - Categories of Confidential Information: Detailed listing of types of confidential information to be shared

3. Schedule 3 - Authorized Recipients: List of individuals or roles authorized to receive confidential information

4. Schedule 4 - Security Protocols: Specific technical and organizational security measures required

5. Schedule 5 - Data Processing Terms: Detailed GDPR-compliant data processing terms if personal data is involved

Authors

Relevant legal definitions
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Relevant Industries
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Relevant Roles
Industries
Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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